Extension Study of AVP-786 in the Treatment of Subjects with Agitation Associated with Dementia of the Alzheimer's Type

Phase 1

• Conditions: Agitation Associated with Dementia of the Alzheimer's Type; MedDRA version: 20.0Level: PTClassification code 10001497Term: AgitationSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-002455-29-BG
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-03
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1. Patient has successfully completed Studies 15-AVP-786 301, 15-AVP-786-302, 17-AVP-786-305, or 12-AVR-131 and is deemed eligible forenrollment by the investigator after review of theinclusion/exclusion criteria. (Note: A delay in enrollment from a prior study requires Medical
Monitor approval and may include delays associated with COVID-19
restrictions.)
8. Patient has stable cardiac, pulmonary, hepatic, and renal function.
10. Patients of childbearing potential who are sexually active must use an effective method of birth control for at least 1 month prior to
randomization, during participation in the study, and for at least 30 days
after the last dose of study drug. The following should be taken into
consideration:
• Patients of childbearing potential must use 2 of the following
precautions in order to minimize the risk of failure of 1 method of birth
control: vasectomy, tubal ligation, vaginal diaphragm, intrauterine
device, birth control pills, birth control depot injection, birth control
implant, or condom with spermicide or sponge with spermicide. Periodic
abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation
methods), declaration of abstinence for the duration of exposure to
study drug, or withdrawal are not acceptable methods of contraception.
• Patients who are sterile (i.e., had an oophorectomy and/or
hysterectomy), postmenopausal (defined as 12 consecutive months with
no menses without an alternative medical cause) or practice true abstinence (when this method is in line with the preferred and usual
lifestyle of the patient) are exempt from this requirement.
• Patients who are lactating, pregnant, or plan to become pregnant are
excluded.
15. For patients who delay enrollment, they must not show current and significant symptoms of a depressive disorder and must have a score <10 in the Cornell Scale for Depression in Dementia (CSDD) at Screening. Patients rolling over from Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305 with scores greater than 10 in the CSDD at baseline should be evaluated by the investigator for enrollment in the current study.
17. Caregiver must be willing and able to comply with study procedures, including not administering any prohibited medications during the course of the study.
18. Patient/caregiver must be willing to sign and receive a copy of patient/caregiver informed consentform (ICF) after the nature and risks of study participation have been fully explained. Patients who are not capable of signing the ICF but are able to provide assent, or the patient's authorized representative (as determined by local regulation) agrees to participation (for patients unable to provide assent) are allowed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1050

Exclusion Criteria

1. Patient is currently participating in, or has participated in other interventional (drug or device) clinical study since exiting Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305, or within 30 days prior to baseline for patients who delay enrollment.
2. Caregiver is unwilling or unable, in the opinion of the investigator, to comply with study instructions.
3. Patients with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy [except skin basal-cell carcinoma] poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease). Certain other nonmetastatic cancer may be allowed. For patients who delay enrollment, each case to be evaluated individually with the Medical Monitor (MM).
4. Patients determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator
6. Patients who are currently using or were on NUEDEXTA® in the 2 weeks preceding Baseline.
7. Patients with evidence of serious risk of suicide at Screening (patients who delay enrollment) and Baseline based on the Sheehan Suicidality Tracking Scale (S-STS), i.e., a score of 3 or 4 on any one question 2 through 6 or 11 or a score of 2 or higher on any one questions 1a, 7 through 10, or 12, or who, in the opinion of the investigator, present a serious risk of suicide.
8. Patients who, in the opinion of the Investigator, Medical Monitor, or
sponsor, should not participate in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the long-term safety and maintenance of efficacy of AVP-786 for the treatment of agitation in patients with dementia of the Alzheimer’s type.;Secondary Objective: None;Primary end point(s): SAFETY: Safety and tolerability of AVP-786 will be assessed by reported adverse events (AEs), physical and neurological examinations, vital signs, clinical laboratory assessments, resting 12-lead electrocardiograms (ECGs), Sheehan Suicidality Tracking Scale (S-STS), Mini Mental State Examination (MMSE), and the Epworth Sleepiness Scale (ESS). Pregnancy tests will be conducted for females of childbearing potential.;Timepoint(s) of evaluation of this end point: AE (every visit), PE (Baseline and V8), VS (every visit minus f/u), CLA (Baseline, V2, V3, V4, V5, V6, V7, V8), ECG (Baseline, V2, V3, V4, V5, V6, V7, V8), S-STS (All visits), MMSE (Baseline, V5 and V8), ESS (Baseline, V5 and V8), Pregnancy (Baseline, V2, V3, V4, V5, V6, V7, V8).